Analytical Treatment Interruption in a Patient With HIV Post Allogeneic Stem Cell Transplantation From a CCR5 delta32 Homozygous Donor

NCT06582797 | Not Yet Recruiting

• 1 other identifier: 160833
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients who have Human Immunodeficiency Virus-1 (HIV-1) infection, who also had a stem cell transplant may have achieved cure of their HIV infection. Once the patients blood shows no detectable levels of HIV virus in their blood collected from a process called leukapheresis, they will be closely monitored while discontinuing their HIV treatment which is know as antiretroviral therapy or, ART. They will be tested regularly and monitored for up to 52 weeks at which point they may be considered cured of their HIV.

Conditions

HIV-1-infection

Keywords

stem cell transplant; HIV proof of cure

Outcome Measures

Primary Outcomes (1)

• Proof of cure

  patient will prove cured of HIV infection if no viral load tests result positive over the duration of study

  52 weeks

Study Arms (1)

treatment withdraw

EXPERIMENTAL

patient with discontinue standard of care treatment for their HIV infection

Other: discontinuation of ART

Interventions

discontinuation of ART OTHER

patient will discontinue their standard of care HIV treatment with ART while being closely monitored

treatment withdraw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive HIV testing
• Has undergone a stem cell transplant

You may not qualify if:

• under 18 years of age
• unwilling to comply with protocol

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institutes of Health (NIH): collaborator

Central Study Contacts

Karen M Snyder, BS, CCRC

CONTACT

913-588-8002; ksnyder6@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2034
• Study Completion (Estimated): September 1, 2034
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share